BEUDAMED
    FDA Recall Terminated

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    Recall: Z-0139-2015 · Initiated October 19, 2014

    Recall

    Recall Number
    Z-0139-2015
    Event Number
    69532
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    October 19, 2014
    Posted
    October 27, 2014
    Terminated
    October 6, 2015
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    Reason

    The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

    Action

    A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family. The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST.

    Distribution

    Nationwide Distribution

    Quantity

    173,329 units total (21,812 units in US)